Intrapleural Gene Transfer for Pleural Mesothelioma (IFN-alpha)

Abramson Cancer Center at Penn Medicine

Status and phase

Completed

Phase 1

Conditions

Malignant Pleural Mesothelioma

Treatments

Biological: SCH 721015

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01212367

P01CA066726 (U.S. NIH Grant/Contract)

UPCC 18508 808806;

Details and patient eligibility

About

This research will study how to activate the immune system by using gene transfer. Gene transfer involves inserting a specially designed gene into cancer cells. A gene is a part of the genetic code that instructs the cells of our bodies to produce specific compounds (proteins) important for the makeup or function of the cell. The study hypothesis is that repeated doses of SCH 721015 given over a three day interval would result in gene transfer.

Full description

Ad.hIFN-α (SCH 721015, adenoviral-mediated interferon alpha) is a replication-defective recombinant adenoviral vector containing the human interferon-alpha (hIFN-alpha) gene. This Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two doses of Ad.hIFN-alpha injected into the pleural (intrapleural, IP) and given 4 days apart in subjects with pleural mesothelioma.

Subjects who meet eligibility will have a pleural catheter placed 2 weeks prior to the first dose. Subjects are then admitted to the research center on Days 1 and 4 for dosing and overnight observation. Subjects are then followed-up as outpatients for a total of 6 months. Radiographic evaluations are repeated on Day 64 and at 6 months. The pleural catheter is removed once it is not necessary.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

evidence of progressive disease after standard first line treatment of mesothelioma; OR patient has refused standard first line treatment of mesothelioma
evaluable disease
No radiotherapy and/or treatment with chemotherapeutic, cytotoxic, or immunologic agents within 14 days prior to infusion of the IFN-α vector
Must have a pleural space involved with tumor accessible for pleural catheter insertion
FEV1> 1 liter or 40% of predicted value
Must have an anti-adenoviral neutralizing antibody titer equal to or less than 1:1000. This will be measured by the Penn Vector Core

Exclusion criteria

Presence of HIV or Hepatitis B infection
Use of concurrent systemic steroids, immunosuppressives, or any other medications that can directly or indirectly suppress the immune system
Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependence, significant chronic obstructive pulmonary disease (COPD), end stage liver or renal disease
Presence of untreated brain metastases
Prior bone marrow or stem cell transplants